First Implantable Sensor System for Wireless Restenosis Detection
Intravascular stents are a common treatment for peripheral and coronary artery disease, with about 540 k procedures in the lower limbs and 1.54 million procedures in the coronaries performed every year in Western Europe. These stents share one huge problem: Restenosis, a gradual re-clogging of the stent over time, occurring in about 5 % - 25 % of all stents within the first 5 years.
Restenosis related mortality rate after 10 years for large vessel arterial disease is up to 75 %. Combating restenosis imposes huge burdens on our healthcare system demanding time consuming diagnostic measures and surgical interventions. The cost of restenosis related follow-up treatments amount to about €121 million per year in Western Europe. At least 80 % (€100 m) of these costs are avoidable by easy-to-use, direct and precise diagnosis.
The VesselSens diagnostic system is the first implantable sensor system that renders traditional check-ups obsolete by allowing patients to accurately diagnose vessel clogging in real-time. Unlike conventional stents which require expensive and highly inaccurate clinical check-ups our patented in-stent sensor technology provides highly accurate wireless diagnosis. Follow up examinations are no longer necessary.
Compared to State-of-the-Art
- Measurements in short intervals
- Early prediction of clogging
- Easy handling, precise and fast diagnosis
- Determination of trends and correlation with further vital parameters is possible
- The restenosis treatment may be induced in an earlier stage
- Success of therapy is detectable and can be monitored
- Improves life comfort and sense of security
- Prevention of relapse
- Reduction of time-consuming check-ups, e.g. physical performance tests, ultrasonic testing
The sensor system is implanted in coronary or peripheral artery during stent implantation or balloon angioplasty.
The read out device is placed on the body where the stent is implanted.
Our sensor system consists of two sensors which are placed at both ends of the stent.
The read out device is passively and inductively coupled with the sensors in the stent and retrieves PWV (Pulse Wave Velocity) data.
The PWV is the speed of the pulse pressure wave propagating through the blood vessel.
It transmits these data to a cloud service.
In the cloud, the VesselSens proprietary restenosis calculation algorithm is stored. Based on the patient specific PWV data, the restenosis degree will be calculated.
The data will be transfered back to the cardiologist or physician within a minute.
It will also be accessable via web interface for clinicians, physicians and patients. For physicians and clinicians there is a possibility to derive trends and detect further important parameters in relation to restenosis.
The result is also shown to the user on the read out device in a traffic light system.
CTO, Project Manager, Engineer, Inventor
- Studied mechatronics at the university of Stuttgart
- Focus on biomedical engineering
- 11 years work experience at Fraunhofer IPA, Stuttgart and LSI, Bonn
Dirk Kautz, PhD
CEO/CFO, Business Developer
- Studied physics at the University of Eugene, Orgon, USA
- Focus on strategic marketing
- 21 years experience in medical devices (BIOTRONIK)
Mechanical Engineer, Ragulatory Affairs, QM (DIN ISO EN 13485)
- Studied Biomechanical Engineering at FH Lübeck
- Focus on mechanical engineering
- Advanced training: manager regulatory affairs
Electrical engineer, Sensor Development, Simulation
- Studied Sensor System Technology at the Hochschule Karlsruhe
- Focus on biomedical engineering
Fig. 1 – Implant with sensors on a delivery system
Fig. 2 – Design study of VesselSens read out device
Fig. 3 – Software & Algorithm
If you are interested in a cooperation please contact us. We are currently in a series A fundraising phase.
Trade sale to a major global stent company is planned in 2022/2023. Since there were no real innovations in the global stent market over the last years, chances are high that, after successful development of the VesselSens system, an attractive trade sale deal with a major global stent company can be made. Potential buyers of the VesselSens assets are global medtech companies.
Prototypes of the sensors and the read out unit as well as the restenosis calculation algorithm are developed, first results of preclinical trials in animal model were positive. It is planned to get a CE mark by the end of 2022.